CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Artemether-lumefantrine combinationdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02600767
NCT02600767N/ACompleted

Evaluating the Efficacy of Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Cruzeiro do Sul, Acre, Brazil

Centers for Disease Control and Prevention·interventional·Posted Nov 9, 2015·Updated Oct 9, 2017

In Brief

A clinical study evaluating Artemether-lumefantrine combination for Malaria. Completed, enrolled 79 participants across 1 site.

Detailed Summary

This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesBrazil

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 9, 2015
Enrollment StartDec 1, 2015
Primary CompletionMay 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.6 years ago

Interventions

Artemether-lumefantrine combinationdrug

This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.